연 번 품명(영문, 국문) 규격 및 사양 총 구매예정수량(Q'TY) 1회 최대 발주수량 WA RANTY기간 단위 (UNIT) 1 Anesthesia Machine (전신마취기) A or B 1 1 검수(합격)일로부터 3년 종료 월말일까지 SET 2 Patient Monitor (마취기용 환자감시장치) A or B 1 1 검수(합격)일로부터 3년 종료 월말일까지
물 품 규 격 서
입찰공고번호 학일xxx 관리국 x x
입찰xx 외래수술실 x x 구매 수요xx xx대학교성xxx
납품장소 수요xx 희망장소 입고도 물품내역 등
연 번 | 품명(xx, 국문) | 규격 및 사양 | 총 구매예xxx (Q'TY) | 1회 최대 발xxx | WA RANTY 기간 | 단위 (UNIT) |
1 | Anesthesia Machine (전신마취기) | A or B | 1 | 1 | 검수(합격)일로부터 3년 종료 월 xx까지 | SET |
2 | Patient Monitor (마취xx xx감시장치) | A or B | 1 | 1 | 검수(합격)일로부터 3년 종료 월 xx까지 |
공통사항
장비의 설치와 작동 및 교육은 xx으로 제공한다
수요xx 담당자 입회 하에 계약상대자는 제품의 설치 테스트 및 시험작동을 실시xxx 한다 xx담보 책임기간은 물품 검수합격 완료일로부터 년 종료 월 xx까지를 기본 원칙으로 하며 계약상대자의 추가 xx에 따라 년 종료 월 xx까지의 기간을 초과하여 설정할 수 있다 xx담보 책임기간 중 수요xx의 xx으로 인하여 부서 및 장비의 위치가 불가피하게 이동을 필요로 할 xx xx 및 설치가 xx으로 이루어진다
xx담보 책임기간 중 공급된 장비의 부속품이 단종된 xx 수요xx이 xx하는 동등 이상의 장비로 xx교체가 이루어져야 한다
계약상대자는 어떠한 xx에서나 애프터서비스를 위하여 전문서비스 인력을 제공xxx 하며 애프터서비스를 위하여 교체 부품을 xxxxx 한다
계약상대자는 장비 납품 시 납품일을 xx하여 제품 제조년월이 개월 이내인 장비를 납품 하고 납품장비에 해당 제조년월이 명시되어야 한다
기존 xx 중인 의료장비 철거 및 xx 또는 xx판매 조건으로 xx할 수 있다
<규격‧사양 A>
◯ Features
[Anesthesia Machine]
1. Movable 15'' touch screen.
2. User configurable 'Quick Picks' for rapid selection of FiO2 and total flow combinations
3. With 'Flow Power Inside' our ventilator engine can ventilate all patient types from neonates to obese adults
4. Sophisticated mechanical ventilation and assisted ventilation options including synchronised PCV-VG with pressure support(SIMV PCV-VG)
5. Compact breathing system specifically designed for lowflow to help provide fast gas kinetics for rapid wash-in and wash-out
6. Continual fresh gas flow with fresh gas flow compensation during mechanical ventilation
7. Central brake
8. Top shelf mounting rails
9. Metal work surface
10. Movable display arm for inbound and outboard positioning
11. Two or three vaporiser positions
12. Bi-level work surface illumination
13. Optional ecoFLOW helps clinicians mitigate the risk of hypoxic mixtures during low and minimum flow
14. Optional ecoFLOW for visualizing agent consumption and help in mitigating wasteful over delivery of fresh gas flow
[Patient Monitor]
1. Wide set of clinical measurements are available with advanced parameter module
2. Innovative algorithms aid in accurate diagnoses
3. Advanced airway modules provide for complete respiratory monitoring with gas exchange measurement
4. Pages & Profiles functionality can increase flexibility and workflow efficiency by allowing you to configure monitors to unit standards and patient populations
5. Auto View on Alarm (AVOA) automatically shares high priority alarms within the care unit
◯ Specifications
[Anesthesia Machine]
1. Modes of ventilation
- Volume Control with tidal volume compensation
- Pressure control
- PCV-VG
- SIMV PCV
- SIMV PCV-VG (Option)
- SIMV VCV (Option)
- CPAP PSV
2. Ventilator parameter ranges
- Tidal volume range: 20 to 1500 ml (Volume control and SIMV mode)
- Incremental settings: 20 to 100 ml (increments of 5 ml), 100 to 300 ml (increments of 10ml), 300 to 1000 ml (increcements of 25 ml), 1000 to 1500 ml (increments of 50 ml)
- Minute volume range: 0 to 99.9 L/min
- Pressure (P inspired) range: 5 to 60cm H2O (increments of 1cm H2O), 5 to 1500ml volume delivery
- Pressure (P limit) range: 12 to 100cm H2O (increments of 1cm H2O)
- Pressure (P support) range: Off, 2 to 40cm H2O (increments of 1cm H2O)
- Rate: 4 to 100 breaths per minute for Volume control and Pressure control; 2 to 60 breaths per minute
- Inspiratory / expiratory ratio: 2:1 to 1:8 (increments of 0.5)
- Inspiratory time: 0.2 to 5.0 seconds (increments of 0.1 seconds)
- Trigger window: 0 to 80% (increments of 5%)
- Flow trigger: 1 to 10L/min (increments of 0.5 L/min), 0.2 to 1L/min (increments of 0.2 L/min)
- Inspiration termination level: 5 to 50% (increments of 5%)
3. Positive End Expiratory Pressure (PEEP)
- Type: Integrated, electronically controlled
- Range: OFF, 4 to 30cm H2O (increments of 1cm H2O)
4. Ventilator performance
- Display size: 15 inch
- Pixel format: 1024 x 768
- Pressure range at inlet: 240 kPa to 700 kPa/ 35 psig to 100 psig
- Peak gas flow: 120L/min + fresh gas flow
- Flow valve range: 1 to 120 L/min
- Flow compensation range: 200mL/min to 15L/min
5. Anesthesia agent delivery
- Vaporizer: Tec7
- Number of positions: 2
- Mounting: Tool-free installation, Selectatec manifold inter locks and isolates vaporizers
6. O2 controls
- Method: N2O shut off with loss of O2 pressure
- Supply failure alarm: Range: 193 kPa to 221 kPa/28 psig to 32 psig, Sounds at maximum volume every 10 seconds
- O2 flush: Range > 35 L/min
7. Alternate O2 (safety flow)
- Range: 500mL/min minimum to 10 L/min
- Indicator: Flow tube
- Indicator accuracy: +-5% full scale
8. Fresh gas
- Flow range: 0 and 500mL/min to 15 L/min (minimal flow capable)
- Total flow accuracy: +-10% or +-40 mL/min of setting
- O2 flow accuracy: +-5% or +-20 mL/min of setting (large of)
- Balance gas flow accuracy: +-5% or +-20 mL/min of setting (large of) Air/N2O
- O2 concentration range: 25% to 100%
- O2 concentration accuracy: +-5% V/V for flows < 1 L/min, +-2.5% setting for flows > 1L/min
- Electronic mixture response time: 500 mS (10% to 90% flow step)
- Hypoxic guard: Electronic
9. Alarm (all audible and visual)
- Tidal volume
- Minute volume
- Patient Apnea
- Low airway pressure
- High pressure
- Sustained Airway Pressure
10. Carbon Dioxide Absorbent Canisters
- Absorbent Capacity: 1000g
- Pressure gauge: -20 to 100 cmH2O
- Bag-to-ventilator switch Type : Bi-stable
Control : Controls ventilator and direction of breathing gas within the circuit
- APL valve :
Range : 0.8 to 70 cmH2O
Tactile Knob Indication at : 30 cmH2O and above
- Materials : All materials in contact with exhaled patient gases are autoclavable, except standard flow sensors
[Patient Monitor]
1. Display
Size : 15 in Touch (diagonal)
Type : Active matrix color TFT LCD Resolution : 1024 x 768 pixels (XGA)
Number of traces : 8 individual, up to 14 with overlays and insets Sweep speed : 0.625, 6.25, 12.5, 25, 50 mm/sec
Configuration :
Automatic configuration according to parameter availability. Manual configuration with up to 8
user-configurable profiles for care-specific configurations, and up to 6 user-configurable display pages for each profile
2. Controls
Standard
Touch screen : Optional, resistive technology Hard keys
3 standard keys: ON/Standby, Home, Pause Audio Alarm 11 additional keys in non-touch version: Trends, Monitor Setup, Data & Pages, Alarm Setup, Procedures, Print Waveforms, Freeze/Snapshot, NIBP Auto, NIBP Start/stop, Parameters, Zero All Pressures
Remote control : Ordered separately
3. Pivoting module frame
. Module capacity : 2 module slot.
. I/O connections : RS-232 computer serial output digital & analogue 10 port.
. 8 freely configurable analogue outputs.
. Network Interface capabilities.
4. ECG
Measurement method 3, 7 and 12 lead ECG with 3, 5 or 10 leadwires
ECG Lead selection "Possible to monitor simultaneously one or more of the following leads: I, II, III, aVL, aVF, aVR, V1, V2, V3, V4, V5, V6"
Heart rate "Measurement range : 30 to 250 bpm Measurement accuracy : ±5 % or ±5 bpm Display resolution : 1 bpm
Display averaging time : 5 seconds Display update time : 5 seconds"
Alarms Asystole, leads-off detection, adjustable high and low alarm limits for heart rate, V Fib, V Tachy, (optional: V Run, V Couplet, V Bigeminy, V Trigeminy, R on T PVC, Missing Beat, Multifocal PVCs, PVC rate alarm)
5. Temperature 2 temperature measurement channels Numerical display T1, T2, T2-T1
Temperature units °C or °F
Measurement range 10° to 45°C/50° to 113°F Display resolution 0.1°C/0.2°F
Measurement accuracy ±0.1°C (25° to 45°C)
±0.2°C (10° to 24.9°C)
Measurement accuracy with single-use sensors ±0.2°C (25° to 45°C)
±0.3°C (10° to 24.9°C)
6. Invasive blood pressure( 2 Channel ) Module
.Channel : up to 6 channel.
.Measurement range : -40 - 320 mmHg.
.Measurement Accuracy : ±5 % or ±2 mmHg.
.Numeric display
Range : -40 - 320 mmHg.
Resolution : 1 mmHg.
.Waveform display
Range : -30 - 300 mmHg.
Scale : adjustable in 10 mmHg increments.
.Alarms : adjustable high and low alarm limits for systolic, diastolic and mean pressures, or off
.Pulse rate
7. NIBP
Range : 30 - 250 bpm.
Resolution : 1 bpm.
Accuracy : ±5 % or ±5 bpm.
Transducer sensitivity : 5μV/V/mmHg, 5 Vdc, max. 20mA
Numerical display systolic, diastolic and mean arterial pressure Measurement principle oscillometric with linear deflation Deflation speed heart rate dependent, 3 to 8 mmHg/s Measurement range adult 25 to 260 mmHg
child 25 to 195 mmHg
infant 15 to 145 mmHg
Pulse rate range 30 to 250 bpm
Measurement intervals "manual and selectable intervals 1, 2.5, 3, 5, 10, 15, 30 min, 1 h, 2 h, 4 h or continuous STAT mode“
Alarms cuff loose, cuff occlusion, adjustable high and low alarm limits for systolic, diastolic, mean
Typical measurement time adult 23 seconds
infants 20 seconds
Safety features adult child Infant Initial. inflation pressure (mmHg) 170 150 120
Max. inflation pressure (mmHg) 280 200 145
Overpressure limit (max. 2 s; mmHg) 320 220 160
Max measurement Time 120 120 75
NIBP measurement meets or exceeds AAMI SP10:2002 standard
Note: NIBP measurement is intended for patients weighing over 5 kg/11 lb.
8. Pulse Oximetry (SpO2)
Measurement method red and infrared light absorption SpO2 Measurement and display range 0 to 100 %
Calibration range 70 to 100 %, calibrated against functional oxygen saturation
Measurement accuracy1) "100 to 70 % SpO2, ±2 digits, ±3 digits during clinical patient motion; 69 to 0 %, unspecified"
Display resolution 1 digit (1 % of SpO2)
Display averaging time adjustable beat-to-beat, normal, slow
Alarms adjustable high and low alarm limits for SpO2, probe off, no probe Pulse rate "Measurement and display range : 30 to 250 bpm
Display resolution : 1 digit (1 bpm) Measurement accuracy : ±5 % or ±5 bpm"
Plethysmographic pulse waveform Scales 2, 5, 10, 20, 50 mod% or automatic scaling
Note: For each SpO2 accessory, refer to the instructions for use in the accessory package for patient weight limits.
9. Neuro-Muscular Transmission Module (NMT)
. Stimulation modes : Train of four, TOF Double burst (3,3), DBS Single twitch, ST
50Hz tetanus & post tetanic count, PTC
. Numeric display : TOF%, DBS%, Count, T1%, PTC
. Measurement intervals for TOF/DBS : Manual, 10sec, 12sec, 15sec, 20sec, 1min
5min, 15min
. Measurement intervals for ST : Manual, 1sec, 10sec, 20sec Stimulus pulse : Square wave, constant current
Pulse width : 100, 200 or 300 μs
. Regional Block mode
Stimulation mode : Single twitch
Stimulation intervals : 1, 2, 3 sec
Stimulus pulse : Square wave, constant current
Pulse wide : 40μs
Stimulus current range : 0 - 5.0 mA with 0.1 mA steps
Stimulus current accuracy : 20% or ± 0.3 mA, whichever is greater
10. Entropy Module
. Based on acquisition and processing of EEG and FEMG signals
. Features two Entropy parameters
- Response Entropy (RE) - a fast reacting parameter for detecting activation of facial muscles.
- State Entropy (SE) - a steady and robust parameter for assessing the hypnotic effect of
anesthetic drugs in the brain.
. Digital display and trending of the Entropy parameters and Burst Suppression Ratio (BSR)
. Entropy EEG Waveform display, one Channel
1) Direct Function keys
. Entropy : Opens Entropy manu
. Check Sensor : Starts impedance measurement of sensor electrodes
2) Amplifier and AD conversion
. Amplification : 10000
. Input dynamic range : ±500uV
. Input offset : ±300uV
. Frequency : 0.5 - 118 Hz
. Sampling frequency : 1600Hz
3) Waveform Display (one Channel of raw EEG)
. Range : 800uVpp
. Scales : ±25/50/100/250/400uV
. Sweep speed : 12.5/25/50 mm/s
4) Numeric Display (RE, SE and BSR)
. Range : RE 0-100, SE 0-91, BSR 0-100%
. Accuracy :±1%
. Display update : 1sec
◯ Consist of (Total)
[Anesthesia Machine]
1. Main Frame Configuration 1EA
2. Electronic Gas Mixer 1EA
3. X-Largr Flexible 15 inch LCD Touch Screen display 1EA
4. 7900 Smart Ventilation System (Software and manual, English) 1EA
5. Ventilation Mode 1EA
- Manual Mode 1EA
- Volume(VCV) Mode 1EA
- Tidal Volume Compensation 1EA
- Pressure Controlled Ventilation (PCV) Mode 1EA
- SIMV Mode 1EA
- PSV Mode 1EA
- PSVPro Mode 1EA
- SIMV-PC Mode 1EA
- PCV-VG Mode 1EA
6. Eco-Flow EcoPower System 1EA
7. True-Neonatal Ventilation System 1EA
8. Two Vaporizer Mounting Manifold System 1EA
9. Auxiliary Common Gas Outlet 1EA
10. Bag Support Arm 1EA
11. Electrical Outlet four socket Assembly | 1EA |
12. Compact Airway Gas Module Slot | 1EA |
13. E-sCAIO Multi Gas Module w/Acc's set(02/C02/N20/5-Agent ID/MAC value) | 1EA |
14. Gas Evacuation System | 1EA |
15. C02 Canister Reusable | 1EA |
16. Integrated Auxiliary Oxygen Flowmeter | 1EA |
17. Continuous Vaccum-3 Mode Suction Assembly | 1EA |
18. 1300 ml Suction Bottle | 1EA |
19. O2 Hose Assembly 15ft w/Adaptor | 1EA |
20. N20 Hose Assembly 15ft w/Adaptor | 1EA |
21. AIR Hose Assembly 15ft w/Adaptor | 1EA |
22. Vacuum Hose Assembly 15ft w/Adaptor | 1EA |
23. Flow Sensor | 2EA |
24. EZ Changer | 1EA |
25. Tec 6 Desflurane Vaporizer | 1EA |
26. Tec 8 Sevoflurane Vaporizer | 1EA |
27. Operation & Service Manual | 1EA |
[Patient Monitor]
1. Main Module Frame with Processor unit 1EA
2. 15 Inch Color TFT LCD Touch Display | 1EA | |
3. Display controller with Up to 8 Channel | Display | 1EA |
4. PDM Parameter Module w/Acc's set (3ch ECG/ST/Resp/NIBP/SpO2/2 Temp/4 | IBP) | 1EA |
5. ECG TRUNK CABLE | 1EA | |
6. ECG 3LEAD WIRE | 1EA | |
7. SPO2 FINGER SENSOR | 1EA | |
8. SPO2 CABLE | 1EA | |
9. NIBP HOSE | 1EA | |
10. NIBP CUFF(ADULT,CHILD) | 1EA | |
11. TEMP CABLE | 1EA | |
12. TEMP PROBE | 1EA | |
13. E-NMT Module | 1EA | |
14. E-Entropy Module | 1EA | |
15. Operator's & Service Manual | 1EA |
◯ Remarks
1. Warranty : 검수(합격)일로부터 3년 종료 월 xx까지
<규격‧사양 B>
◯ Features
[Anesthesia Machine]
1. The anesthesia machine must be suitable for general and regional anesthesia of adults, children and neonates without changing components (only patient breathing circuit).
2. The anesthesia machine must be suitable for automatic and manual ventilation as well as spontaneous breathing with or without pressure support.
3. The anesthesia machine must be suitable for low and minimal flow anesthesia:
- fresh-gas-flow adjustable down to 0,2 [L/min]
- active conditioning of breathing gas and moisture prevention (e.g. breathing system heater)
- Intelligent tool for control of low flow anesthesia and prevention of fresh gas deficits or too high consumption
- Support of appropriate oxygen concentration settings by prediction of the inspiratory O2 concentration for the next 20 minutes as minimal flow support (optional).
- Support of appropriate vaporizer settings by prediction of the inspiratory and expiratory anesthetic agent concentration for the next 20 minutes as minimal flow support (optional).
4. The anesthesia machine must be equipped with an integrated monitoring for ventilation, patient gas and device.
5. Ventilation and patient gas monitoring for the display and control of all legally required measuring and monitoring parameters integrated in the basic unit and shown on central touchscreen.
6. The anesthesia machine must be equipped with an auxiliary O2 flow dosage for O2-Insuflation integrated into the base unit. The auxiliary O2 flow meter for O2-Insuflation must be illuminated.
7. The anesthesia machine must be equipped with an anesthetic gas scavenging system integrated into the base unit. The correct functionality of the anesthetic gas scavenging system has to be indicated at the device, so that a user in front of the device can check the correct functionality – available even if system is “off”.
8. The anesthesia machine must be specified for operation in 4000 m above sea level.
9. The anesthesia machine must be completely free from Latex.
[Patient Monitor]
1. Lets you monitor vital signs and therapy, view and control alarms, review Web-based diagnostic images, access patient records, and scale up functionality based on patient acuity level - all at one place
2. Integrates real - time data, clinical applications, the hospital network and the Internet at the point of care
3. Continuously displays vital signs on at least half of the Medical Cockpit screen while allowing
access to other relevant medical information on the split screen
4. Scale up or down your solution depending on your patient's acuity by adding parameters, device connectivity and an optional secondary display
5. This monitor can be used as a stand alone monitor or as the transport component of the central monitor.
6. This monitor continuously captures and displays hemodynamic monitoring data at the bedside and on transport in the hospital
7. This monitor transmits vital signs data both wired (when docked) and wirelessly (on transport)
8. This monitor automatically backfills vital signs data collected on transport into the medical cockpit upon docking
9. Trends
1) Provides up to 96 hours of trends on the system, 72hours on the monitor transport component
2) Trends and events gathered on transport are automatically available at the Cockpit upon arrival
3) Data resolutions 30-second sampling
4) Trend table 1minute, 5minute, 10minute, 15minute(default), 30minute, 1hour display formats
5) Trend graphs 1hour(default), 2hour, 4hour, 8hour, 12hour, 1day, 2day, 3day, 4day display formats
10. Alarm History and Events
1) Alarm history review allows a retrospective view of significant events in the patient's history
2) Event storage provides up to 150 events, 20-second strips, all monitored waveforms
11. Views and Profiles
1) The user may choose up to 8 pre-configured view, and 8 custom views (with View Editor option) including split-screen views, where at least half of the available screen real estate is dedicated to real-time patient information
2) Views are configured depending on the care area needs and optionally support user-customizable views
3) User can configure up to 4 profiles per patient category, thus adapting alarm limits and parameter settings depending on the patient, the acuity, and the environment.
12. Lung Recruitment Application
1) Displaying direct relation between hemodynamic and ventilation data allows clinicians to assess the effect of therapeutic procedures
2) A comprehensive trend page for visualizing information necessary to perform a recruitment maneuver.
The page shows the effects on lung mechanics and hemodynamic parameters on a single, integrated display.
The Recruitment page displays twelve minutes of data for a maximum of 9 parameters, which are configurable.
13. Lab data
Available optionally with the gateway without requiring an central station.
14. Calculations
1) Physiological (hemo/oxy/vent) calculations - optional
Calculations can be performed using automatically entered values (as a result of algorithm processing), or manually entered values
2) Drug dosage calculations
Customizes a drug list of up to 40 drugs
◯ Specifications
[Anesthesia Machine]
1. Central Gas Supply
- Operating range : 2.7 to 6.9 bar for use with O2, Air and N2O
- Display for Central gas supply pressure measured by device and alarm condition for O2, Air and N2O
2. Power supply
- Standard device with 4 IEC power sockers for supply of other devices.
- All power sockets protected and hidden behind cover
- Insulation transformer with main switch and 4 country specific power sockets (4x 3 A, max. 7.5 A) with individual circuit breakers. (optional)
3. Interfaces
- Two serial ports for external data transfer for all measuring and monitoring parameters integrated in the basic unit.
- USB port supporting storage of information (screenshots and data).
- Transport of device configuration from one device to others via USB stick (views, alarm settings, ventilation pre-settings).
- LAN (RJ45) interface
4. Fresh gas delivery
- Automatic actuation of fresh gas flow on start of ventilation
- Settings for fresh gas delivery with direct access from device screen (one touch).
- Fresh-gas flow settings from “off”, 0.2 to 15 L/min.
- Allows low flow and minimal flow anesthesia with fresh-gas flow down to 0.2 L/min.
- Electronic regulator to ensure an oxygen concentration in the nitrous oxide
- oxygen mix of at least 25 Vol.% (ORC).
- Integrated additional oxygen delivery with flow tube adjustable via knob from 0 to 10 L/min.
- Integrated additional oxygen delivery running through the active Vapor.
- Electronically switched, external common gas outlet (CGO) for semi-open breathing systems (optional).
5. Therapy
1) Ventilation performance
- Electornically controlled and electrically driven ventilator(No driving gas consumption)
- Applied tidal volume irrespective of the level of fresh gas flow without delay (fresh gas decoupling).
- Breathing system volume less than 2.2 L (without breathing hoses).
- Dynamic compliance correction
2) Ventilation Modes setting ranges and technical data
- Inspiratory peak flow up to 180 L/min.
- Respiratory frequency: 3 to 100 [1/min]
- Minimal frequency for apnea ventilation: Off, 3 - 25 [1/min].
- Inspiratory time Tinsp: 0.2 -10 [s].
- Inspiratory pause: 20 to 60 [%].
- Slope (pressure rise time): 0.0 to 2 [s]
- Inspiration termination criterion 5 to 80 [%].
- Insp. stroke volume (VC): 20 to 2000 [ml].
- Selectable flow trigger: 0.3 to 15 [L/min].
- Inspiratory airway pressure (PC): 3 to 80 [hPa].
- Pressure limitation Pmax: 7 to 80 [hPa].
- PEEP: Off, 2 to 35 [hPa]
- CPAP: 0, 2 to 35 [hPa]
- Parallel adjustment of inspiratory pressure possible in case of change of PEEP (selectable default setting).
- Insp. stroke volume in pressure-controlled ventilation : 0 to 3000 [mL]
- Integrated adjustable positive pressure valve (APL) with adjustment range: 0 to 70 [hPa]
- Integrated adjustable positive pressure valve (APL) with safety function for immediate manual pressure relief of breathing system (POP-Off) without changing the adjusted pressure
3) Therapy supporting functions
- Patient-specific pre-setting of fresh gas quantity and fresh gas composition available in Standby mode
- Configurable pre-setting of patient category, age, height and weight
- Automatic pre-setting of ventilation parameters vt and RR with configurable settings dependent on patient age and patient category
- Active breathing system heater can be switched off manually if there is a special need for therapy
6. Connections for Vaporizers
- For connection of at least two removable vaporizer modules for anesthetic agent delivery integrated in the basic unit
- For flow control of the following volatile anesthetic agents:
- Automatic prevention of the dosage by more than one vaporizer at the same time without user interaction (other vaporizers blocked).
- Vaporizer setting electronically monitored. Can be shown on the main user interface of the anesthesia device.
- Dedicated alarm condition for Sevoflurane and Isoflurane vaporizer below minimum filling level
- Illumination of vaporizer setting and filling level
- Support of vaporizer control by different illuminations for “off” ,“on” and alarms
- Support of appropriate vaporizer setting by prediction of the inspiratory and the expiratory anesthetic agent concentration for the next 20 minutes(minimal flow support). Optional
7. Anesthetic gas scavenging system
- Integrated volume-buffered anaesthetic gas scavenging conforming to EN 740.
- Anesthetic gas scavenging system with direct connection for transmitting gas from open systems.
8. Bronchial aspirator
- Anesthetic gas scavenging system with direct connection for transmitting gas from open systems.
- Integrated precision control of suction rate.
- Integrated manometer for vacuum display
9. User Interface
- 15.3" color touch screen
- Adjustable screen brightness
- Consistent and intuitive operating philosophy for all system modules. Control of all functionalities of gas dosage and ventilation with touch screen and one central rotary knob.
- Adaptation to ambient light conditions by 3 display modes (Day-light / Day dark / Night).
- Pre configured screen setups can be selected with fast access
10. Data, Waveforms, trends and loops display
- Waveforms: Airway pressure, insp. and exp. flow, volume (with loops), O2, CO2 and primary anesthetic agent
- Waveform display color selectable
- Wave renewal speed for all real-time waves individually adjustable: 6.25 mm/s, 12.5mm/s, 25mm/s
- Split-screen function for continuously displaying short-term trends.
- Split-screen function for continuously displaying volume pressure and flow volume loops.
- Graphical trend display of all measured parameters with zoom and cursor functions. (etN2O, etCO2, FiO2, insp. and exp. Volatile Anesthetic Agent, MV, VT, RR, Lung Compliance PIP, Pplat, PEEP, Pmean, R, xMAC)
- Logbook/Trend memory for up to 20000 entries.
- Fresh gas consumption for all gases delivered by mixer (0 to 999 L).
- Volatile anesthetic agent consumption taken from vaporizers (0 to 3000 L).
11. Alarms
- Audible and visual alarm priority within the alarm classification (Warning, Caution, Advisory).
- Alarm information page displaying all active alarms with possible cause and remedy.
- Configurable pre-settings of alarm limits dependent on patient category.
- Possibility to automatically adapt several alarm limits respective to current measured values (AutoSet).
- displayed parameters with exceeded alarm limits are highlighted by alarm color code.
- Direct access to exceeded alarm limits for alarms with adjustable alarm limits by touch on respective parameter
- Possibility to suppress alarms in special alarm groups(e.g for Man/Spon and Cardiac Bypass Mode and CO2 alarms off)
- Alarms for Ventilation Monitoring
- Disconnection alarm for the measured parameters expiratory volume, airway pressure and CO2 concentration.
- Stenosis alarms for the measured paramterers expiratory volume, airway pressure, CO2 concentration and flow
- Airway pressure upper and lower limit
- Monute volume upper and lower limit
- System leak and fresh-gas deficiency alarm
- Alarm for too high insp. Resistance & volume
- Alarm if expiration time is too short
- Alarm for Breathing Gas Monitoring
- Insp. Concentration of volatile anesthetic agent upper & lower limit
- Alarm for exceeding 3 MAC and 5 MAC
- FiO2 upper & low limit
- FiCO2 upper, etCO2 upper & etCO2 lower limit
- inN2O high alarm(limit 82(Vol%)
- Automatic activated MAC-low alarm for depth of anesthesia(configurable)
- Alarm for blocked sample gas line and filled water trap
- Alarms for all sensor failures
- Alarm, if 2nd anesthetic agent is detected
- Alarm, if 3rd anesthetic agent is detected
12. Monitoring
1) Airway Pressure Measurement
- Measuring principle for airway pressure measurements: piezo resistive.
- Measuring range : -20 to 120 hPa
- Accuracy:± 4% or 2 hPa
- Monitoring parameters : Peak,Pmean,Pplat,PEEP, real-time pressure wave and PV loop
2) Flow Measurement
- Measuring principle for all flow sensors : hot-wire anemometry
- Integrated flow measurement without additional cable
- Fully automatic calibration w/o accessories
- All volume measured values displayed in BTPS
- Tidal volume VT measuring range : 0 to 2500mL
- Accuracy : ± 8% or ± 15mL
- Volume measured quanitiies related to minutes
- Total minute volume
- Fraction of spontaneous minute volume and mechanical minute volume
- Measuring range: 0 to 40 L/min
- Respiratory rate
- Total breathing frequency
- Spontaneous breathing frequency
- Mechanical breathing frequency
- Measuring range : 1 to 150L/min
- Accuracy: ± 1/min or ± 10%
- Online measurement of lung compliance( 0 to 250ml/hPa)
- Online measurement of lung resistance( 0 to 999hPa/L/s)
- Online measurement of lung elastance( o to 5 hPa/L)
- Real-time PV/FV loops measuring range: - 120 to 120 L/min
- Real-time PV/FV measuring range : 0 to 2000 mL
3) Breathing Gas Monitoring
- Breathing gas monitoring integrated in the basic unit for displaying and operating all measured and monitored parameters required by law
- Side- stream measurements via sample gas line
- Standard sample line for all patient categories(no need for change)
- Sampling rage: 200ml/min
- Sample gas reuren into the breathing system
- Water trap protected against water perforation and with integrated microbial filter
- O2 Measurement : Paramagnetic, no consumption and free from wear
- Measuring range : 0 to 100 Vol%
- Accuracy: ± 2.5 Vol%+ 2.5% rel.
- CO2 Measurement
- Measuring range : 0 to 13.6 Vol%
- Accuracy: ±0.43 Vol%+ 8% rel.
- Automatic wake-up function
- N2O Measurement
- Measuring range : 0 to 100 Vol%
- Accuracy: ±2 Vol%+ 8% rel.
- Anesthetic Agent Measurements:
- Halothane(H) : 0 to 8.5 Vol%
- Isoflurane(I) : 0 to 8.5 Vol%
- Enflurane(E) : 0 to 10 Vol%
- Sevoflurane(S) : 0 to 10 Vol%
- Desflurane(D) : 0 to 20 Vol%
- Accuracy: ± 0.2 Vol%+ 15% rel.
- Automatic identification of volatile anesthetic agents
- Automatic identification of volatile anesthetic agents of two volatile anesthetic agents in
gas mixtures
- Age corrected MAC calculation which takes anesthesia gases and nitrous oxide into consideration.
13. Integrated Metabolic Monitoring and Consumption Calculation
- Calculation and display of anesthetic agent and gas consumption per OR case
- Continuous and resettable display of anesthetic agent and gas consumption
14. Device test & Safety system
- Automatic ventilation still possible even in the event of any kind of external el. or gas supply failures.
- Manual ventilation possible at least with fresh-gas O2 delivery and dosage of volatile agents in case of system failure / system “off”
- Integrated airway pressure monitor even in case of system failure / system “off”
- Battery backup system at least 30 min to max.150min.
- Completely automatic system test for all sensors,valves,leakage and compliance
- System test may be canceled at any time for immediate therapy start.
- System test offers to be continued where it stopped after fault remedy
- Full automatic timer controlled device power-on and self test with display of the time of device availability even during system “off”
- Assistance system for automatic reminder of required consumable change after specified intervals during system test and standby(Water trap expiration time, Sodalime exchange time)
[Patient Monitor]
1. Connectors
1) Input/output ports
- 3 external RS232 (9-pin) connectors
- 4 USB ports (on the back panel)
- 1 DVI for digital video output (secondary display - same image as Medical Cockpit)
2) System connector
- Connector for system cable (22pins)
2. Physical Attributes
1) Dimensions (H x W x D)
- 322 x 416 x 122mm (12.68 x 16.38 x 4.8 in)
2) Weight (without mounting)
- 7kg (15.43lbs)
3) Cooling
- Convection
4) User interface
- Touch screen, rotary knob and/or via keyboard and mouse
5) CPU
- Intel® Celeron® M723ULV
6) Memory
- 1GB (1x SO-DIMM DDR-3)
7) Maximum power consumption
- ＜55 Watt
3. Display Specifications
1) Screen resolution (max)
- 1440 x 900
2) Colors
- 16.7 million colors
3) display type
- 431.8mm (17.0 in) TFT widescreen LCD
4) Alarm bar
- Integrated into front bezel, 360-degree viewing angle
4. ECG
1) Acquires up to 12 leads
- 3-lead wire set : I, II, III (user-selectable)
- 5-lead wire set : X, XX, XXX, xXX, xXX, xXX, X
- 6-lead wire set : X, XX, XXX, xXX, xXX, xXX, X, X+
- 10-lead wire set : I, II, III, aVR, aVL, aVF, V1-V6
- Trust derived 12-lead on : I, II, III, aVR, aVL, aVF, dV1, V2, dV3, dV4, V5, dV6
2) Measurement
- 15 to 300 beats per minute (bpm)
- ±2 bpm or ±1% (whichever is greater)
3) Resolution
- 1 bpm
4) Frequency ranges
- Monitoring filter : 0.5 to 40Hz
- OR Mode/ESU filter : 0.5 to 20Hz (pacer detection disabled)
- Diagnostic ECG Bandwidth : 0.05 to 150Hz
- OFF filter : 0.05 to 150Hz
5. QRS detection range
1) Amplitude
- 0.5 to 5mV p-p RTI (peak to peak with respect to input)
2) Duration
- Adult : 70 to 120ms
- Pediatric/Neonatal : 40 to 120ms
3) Alarms
- User selectable upper and lower limits
6. Pacer detection (adult/pediatric)
1) Sensing leads :
- Leads : I, II or III
2) Amplitube (a)
- ±2 to ±900 mV
3) Width (d)
- 0.2 to 2.0 ms
4) Rise/Fall times (min)
- 0.1 dp ≤ 100us
5) Overshoot (min)
- 0.025 to 0.25 ap ＜2mV
6) Recharge time constand
- 4 to 100ms
7. ST (adult/pediatric)
1) Sensing leads :
- Any ECG lead available based on lead set used
2) ST complex length
- 828 ms (-260 ms to 568 ms from fiducial point)
3) Sample rate
- 250 samples/s
4) Isoelectric measurement point
- Adjustment range : -260ms to 40ms
- Default : QRS onset -28ms
5) ST measurement point
- Adjustment range : -28ms to 568ms
- Default : QRS offset +80ms
6) Update interval
- 15s ±1s, 1normal beat required
7) Measuring range
- -15.0mm to 15.0mm (-1.50 to 1.50mV)
8) Measuring accuracy
- ±0.1mm (±0.01mV) RTI (with respect to input)
9) Resolution
- ±0.1mm (0.1mV)
10) Alarms
- User selectable upper and lower limits
11) Event duration
- Off, 15,30,45,60s (default 60s)
8. Arrhythmia
1) Basic arrhythmia
- Asystole, Ventricular Fibrillation, Ventricular Tachycardia, Artifact
2) Full arrhythmia
- Basic plus Ventricular Run, Accelerated Idioventricular Rhythm, Supra-Ventricular Tachycardia, Couplet, Bigeminy, achycardia, Bradycardia, Pause, PCV/min
9. PCV/min
1) Measurement range
- 0 to 300bpm
2) Resolution
- 1bpm
3) Accuracy
- ±5 bpm or ±10 % of the rate, whichever is greater
4) Response time
- ＜4 seconds
10. Diagnostic ECG
1) Diagnostic program
- Glasgow Interpretive ECG
2) Interpretation base
- Age, gender, race, medication, clinical classification
3) Report formats
- 13 different report formats available
4) Report languages
- English, French, German, Italian, Portuguese, Spanish, Swedish
5) Export
- Central station can be configured to automatically export 12-lead reports
6) Reports provided by
- Central station with Rest ECG Option enabled
11. Respiration rate
1) Sensing leads
- I, II (user-selectable)
2) Measuring method
- Impedance pneumography
3) Auxiliary current
- ＜10µA for any active electrode
4) Bandwidth
- (-3 dB) 0.25 to 3.5Hz
5) Detection threshold
- 0.2Ω - 4.0Ω in manual mode (user adjustment)
- 0.3Ω - 1.5Ω in auto mode (automatic adjustment)
6) Measuring range
- 0 to 155 breaths per minute
7) Resolution
- 1 breath per minute
8) Measuring accuracy
- 0 to 155 breaths per minute
9) Apnea detection interval times
- Off, 10,15,20,25 and 30s
10) Alarms
- User-selectable upper and lower respiration rate
12. Pulse Oximetry (SpO2)
1) Displayed parameters
- Saturation (fraction of oxyhemoglobin to functional hemoglobin) and pulse (rate and curve), perfusion index (Masimo SET® only);
SpHb, SpOC, SpMet, SpCO, PVI (with Masimo rainbow SET®)
2) Measuring range
- SpO2 : 1 to 100%
- Pulse rate : 26 to 239 bpm
13. Non-Invasive Blood Pressure (NIBP)
1) Parameter display : Systolic, Diastolic, Mean
2) Measuring method : Oscillometric via step deflation
3) Modes of operation : Manual (single measurement), Interval, Contrnuous, or Venous Stasis 4) Interval times : Off, 1,2,2.5,3,5,10,15,20,25,30,45,60,120 and 240min
5) Static cuff accuracy : ±3 mmHg (±0.4 kPa)
6) Resolution : 1mmHg (0.1kPa)
14. Measuring range (default)
1) Heart rate : 30 to 240 bpm
15. Adult
1) Systolic : 30 to 250mmHg (4 to 33.3 kPa)
2) Mean : 30 to 230mmHg (4 to 30.6 kPa)
3) Diastolic : 10 to 210mmHg (1.3 to 28 kPa)
16. Pediatric
1) Systolic : 30 to 170mmHg (4 to 22.6 kPa)
2) Mean : 30 to 150mmHg (4 to 20 kPa)
3) Diastolic : 10 to 130mmHg (1.3 to 17.3 kPa)
17. Neonatal
1) Systolic : 30 to 130mmHg (4 to 17.3 kPa)
2) Mean : 30 to 110mmHg (4 to 14.7 kPa)
3) Diastolic : 10 to 100mmHg (1.3 to 13.3 kPa)
18. Cuff Pressure
1) Default inflation pressure
- Adult : 160 ±5mmHg (21.3 ±0.66 kPa)
- Pediatric : 130 ±5mmHg (17.3 ±0.66 kPa)
- Neonatal : 110 ±5mmHg (14.7 ±0.66 kPa)
2) Inflation pressure after a valid measurement (Accurate within ±5mmHg or ±0.66 kPa)
- Adult : Previous NBP Systolic +25mmHg (3.33 kPa)
- Pediatric : Previous NBP Systolic +25mmHg (3.33 kPa)
- Neonatal : Previous NBP Systolic +25mmHg (3.33 kPa)
3) Maximum inflation pressure
- Adult : 265 ±5mmHg (35.3 ±0.66 kPa)
- Pediatric : 180 ±5mmHg (24 ±0.66 kPa)
- Neonatal : 140 ±5mmHg (18.6 ±0.66 kPa)
4) Minimum inflation pressure
- Adult : 110 ±5mmHg (14.7 ±0.66 kPa)
- Pediatric : 90 ±5mmHg (12 ±0.66 kPa)
- Neonatal : 80 ±5mmHg (10.6 ±0.66 kPa)
5) Connector
- Quick-release connector with single airway
19. Invasive Blood Pressure
1) Measuring method
- Resistive strain gauge transducer
2) Resolution
- 1mmHg (0.1 kPa)
3) Measuring range
- -50 to 400mmHg (-6.6 to 53.3 kPa)
4) Dynamic range
- -250 to 600mmHg (-33.3 to 80 kPa)
5) Frequency ranges
- User selectable DC to 8Hz, DC to 16Hz
6) Accuracy
- ±1mmHg or ±3% (whichever is greater )exclusive of transducer
7) IBP Update interval
- 4s
8) Response time (at 90% of pressure change)
- 14 beats +2s (ART, LV, GP1, GP2, GP3, GP4)
- 8 beats +2s (PA, RV)
- 16s (CVP, RA, LA, ICP)
9) Transducer specifications
- Transducers with a resistance of 200 to 3000Ω and an equivalent pressure sensitivity of 5µV/V/mmHg ±10%
20. Carbon dioxide
1) Displayed parameters
- End-tidal CO2 (etCO2), inspired CO2 (inCO2), respiration rate (RRc)
21. Measurement range
1) CO2
- 0 - 100mmHg (0 to 13.3 kPa or 0 to 13.2 vol% at sea level)
- CO2 partial pressure
2) RRc
- 0 to 150 bpm
22. Temperature
1) Parameter display
- Temperatures ; Ta, Tb, △T, T1a, T1B, △T1
2) Measurement range
- Ta, Tb, T1a, T1b : 0℃ to 50℃ (32℉ to 122℉)
- △T, △T1 : 0℃ to 39℃ (0℉ to 102.2℉)
3) Resolution
- 0.1℃ (0.1℉)
4) Absolute temperature accuracy
- ±0.1℃ (±0.2℉)
5) Delta temperature accuracy
- ±0.2℃ (±0.4℉)
6) Probe accuracy
- ±0.1℃ (±0.2℉)
7) Average update time
- ＜ 2.5s
8) Response time
- 23 to 44℃ (73.4 to 111.2℉), ±0.2℃ (±0.4℉) within 150s
23. Display Product Specifications
1) Display type
- Color Liquid Crystal Display (LCD), Advanced Touch Screen
2) Size
- 158mm (6.2in) diagonal
3) Viewing area
- 149mm x 54mm (5.9in x 2.1in)
4) Resolution
- 640 x 000 (0/0 XXX)
0) Xxxxxxxxxx
- 00 cd/m2 minimum during battery operation; 120 cd/m2 minimum when powered via M500
24. User Interface
1) Controls
- Touch screen plus 3 fixed push-button keys, 8 control keys
2) Alarms
- Audible and visible alarm indication
- Alarm levels : High, Medium, Low
- 45dB(A) ; full volume is ＞70dB(A)
3) Alarm bar
- High (Life Threatening) : Flashes red
- Medium (Serious) : Flashes yellow
- Low : Does not light or flash
25. Information Management Capabilities
1) Trend storage
- Up to 72 hours of parameter information
2) Trend data resolution
- Up to 30s
26. Monitor
1) Dimensions (H x W x D)
- 89 x 259 x 43mm (3.5 x 10.2 x 1.7in)
2) Weight
- Less than 920 grams (2.0 lbs)
3) Cooling
- Conduction when docked, convection when undocked
4) Connections
- ECG, CO2, Hemo, Temperature/Auxiliary, SpO2, NIBP-input
27. Docking station
1) Dimensions (H x W x D)
- 195 x 101x 107mm (7.7 x 4.0 x 4.2in)
2) Weight
- 1200 grams (2.6 lbs)
3) Cooling
- Convection
4) Connections
- System cable, Nurse call (only as part of IACS)
5) Mount interface
- VESA 75
28. Monitor
1) Power source
- Internal lithium ion battery or external power from docking station
2) Battery pack
- Li-ion : 3.75 VDC, 4400 mAh
3) Protection class
- Internally powered (per IEC60601-1)
4) Mode of operation
- Continuous (with power coupling via docking station)
5) Patient leakage current
- ＜10 µA (at both 110V/60 Hz and 220 V/50 Hz)
29. Battery Specifications
1) Battery operating time
- Normal operation : approximately 3 hours
- Power save mode : approximately 4 hours
2) Battery Recharging Time
- 100% capacity : approximately 6.5 hours for completely discharged battery
- 70% capacity : approximately 4 hours for completely discharged battery
30. Docking station
1) DC input
- +24 VDC nominal, 1.5A (+18 o +30VDC)
2) Protection class
- For use with specified class I power supply
3) Mode of operation
- Continuous
4) Power output
- Provides power to Infinity M540 via direct contract charging
◯ Consist of (Total)
[Anesthesia Machine]
1 Basic unit, spec. power outl | 1pc |
2 3-gas mixer, standard | 1pc |
3 Flexible breathing bag arm | 1pc |
4 AGS scavenging hose 5m | 1pc |
5 Drawer module, standard | 1pc |
6 SW Pressure Support | 1pc |
7 Spirolife | 1pc |
8 Sample line | 1pc |
9 Mask face tent O2 star S | 1pc |
10 Mask comfort Star6 stand, w.hook | 1pc |
11 Filter Safestar 80 | 1pc |
12 Infinity ID waterlock 2 | 1pc |
13 O2 ZV - Hose 5m DISS US KAWA | 1pc |
14 N2O ZV - Hose 5m DISS US KAWA | 1pc |
15 AIR ZV - Hose 5m DISS US KAWA | 1pc |
16 Vapor 3000 Sevoflurane | 1pc |
17 D-Vapor 3000 | 1pc |
18 Option Vapor View, HW and SW | 1pc |
19 Regulator, O2, Pin Index | 1pc |
20 SW option O2 preview | 1pc |
21 SW option O2 Lowflow Wizard | 1pc |
22 SW option Econometer Trend | 1pc |
23 Operating manual | 1pc |
[Patient Monitor]
1. Main Unit (17" TFT wide touch screen) | 1SET |
2. M540 Monitor | 1EA |
3. ECG 3-Lead single-pin Euro/AHA 1m | 1EA |
4. ECG Extension single-pin, 2m | 1EA |
5. Cable-Nellcor Oximax | 1EA |
6. SpO2 Nellcor Cable 1.2m | 1EA |
7. SpO2 Nellcor Sensor DS100A | 1EA |
8. Temp. Adapter | 1EA |
9. NBP Cuff M, 23-33cm | 1EA |
10. NBP Cuff S, 17-25/29cm | 1EA |
11. NBP Cuff L, 31-40cm | 1EA |
12. NBP Extension hose, adult, 3.7m | 1EA |
13. Dual HEMO(2IBP) | 1EA |
14. IBP Transducer Cable | 2EA |
15. Mounts for anesthesia machine | 1SET |
16. Operator's and service manual | 1SET |
◯ Remarks
1. Warranty : 검수(합격)일로부터 3년 종료 월 xx까지